Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201805003379263 Date of Approval: 09/05/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Positive deviance approach for exclusive breast feeding practice
Official scientific title Community based Newborn and Infant Breast Feeding Practice Using Positive Deviance Approach: Non-Randomized Controlled Trial OR Effect of Using Positive Deviance Approach on exclusive breast feeding practice in Jimma Town: Community based controlled trial
Brief summary describing the background and objectives of the trial The World Health Organization guidelines for essential newborn and infant care encompass initiation of breast feeding, and exclusive breast feeding. Breast milk provides all infants nutritional and fluid needs in the first six months and is a perfect combination of proteins, fats, carbohydrates and fluids and it is the best and cost effective intervention to reduce infant morbidities and mortalities. Therefore, optimal breastfeeding is recommended; i.e. Exclusively breastfed for the first six months and continuation of breastfeeding up 24 months or beyond. Positive deviance (PD) is an approach to behavioral and social change based on the observation that in any community there are people whose uncommon but successful behaviors or strategies enable them to find better solutions to a problem than their peers, despite facing similar challenges and having no extra resources than their peers. Now a days, low social interaction become a common phenomena which is more observable in urban residents that may affect experience sharing on breast feeding practice. Hence, the general objective of this study is to assess the effect of positive deviance approach on exclusive breast feeding practice at community level using positive deviants.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) EBF
Disease(s) or condition(s) being studied Exclusive Breast feeding/Nutrition,Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/03/2018
Actual trial start date 10/03/2018
Anticipated date of last follow up 10/09/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 260
Actual target sample size (number of participants) 260
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
IHRPGS/2095/2018
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Home based counseling on exclusive breast feeding 6 times (before delivery once, on the day of delivery twice and then four time every month for 6 months at each visit the trained positive deviate will counsel the mother about the advantage of exclusive breast feeding and related issues 130
Control Group Home based counseling on exclusive breast feeding practice Not applicable follow up for 6 months No any intervention given just the mothers enrolled to the control group will be followed and the data will be collected parallel with intervention group. But the usual governmental community based health service will be ongoing 130 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Selected mothers who are in third trimester of pregnancy(32-36 weeks of gestational age or visibly pregnant)during enrollment period AND Mothers who had gave live birth in the last 5 years AND able to provide informed consent and no plans of moving away the following year from the current residential area Mothers with known medical/physical problem that affect breast feeding AND/OR Mother whose baby died at birth and pre-term births (will lose first visit which will be at 37-40 weeks) 15 Year(s) 15 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/01/2018 IRB of institute of health Jimma University
Ethics Committee Address
Street address City Postal code Country
Jimma University Jimma 00000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of exclusive breast feeding and the effect of intervention Baseline will be assessed before birth, Midline will be assessed at 3rd month of post partum, Endline will be assessed at 6th month of post partum.
Secondary Outcome change in attitude and knowledge of exclusive breast feeding practice Baseline will be assessed before birth, Midline will be assessed at 3rd month of post partum, Endline will be assessed at 6th month of post partum for comparison of the result
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Control group recruited from 3 Kebeles (Hermata Merkato, Mentina & Bossa Kito) Jimma Town Jimma 378 Ethiopia
Intervention groups recruited from 3 Kebeles (Ginjo gudiru, Awetu Mendera & Mendera Kochi) Jimma Town Jimma 378 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
International institute for primary health care-Ethiopia in collaboration with John Hobkins University from USA Gulele subcity Addis Abeba Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International institute for primary health care-Ethiopia Gulele Sub-city Addis Ababa Ethiopia Charities/Societies/Foundation
Secondary Sponsor Jimma University Jimma Town Jimma 378 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Johns Hopkins University-JHU 3400 N. Charles St. Baltimore, Maryland 21218 Fax:(410) 516-6097 United States of America
FMOH-Ethiopia Lideta sub-city Addis Ababa P.O.BOX.1234 Ethiopia
FMOH-Ethiopia Lideta sub-city Addis Ababa P.O.BOX.1234 Ethiopia
FMOH-Ethiopia Lideta sub-city Addis Ababa P.O.BOX.1234 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yibeltal Siraneh yibeltal_siraneh@yahoo.com +251917017092 Kochi-Road
City Postal code Country Position/Affiliation
Jimma 378 Ethiopia Lecturer of Health System Management, Reform & Academic Quality assurance coordinator
Role Name Email Phone Street address
Public Enquiries Seble Wengel seblewengel@iifphc.org 0118276789 Gulele sub-city
City Postal code Country Position/Affiliation
Addis Ababa 1242 Ethiopia Research coordinator at iifphc-E
Role Name Email Phone Street address
Scientific Enquiries Mirkuzie Woldie Mirkuzie@yahoo.com +251917804051 Kochi-Road
City Postal code Country Position/Affiliation
Jimma 378 Ethiopia Professor of health management and policy, Senior research advisor at FMOH
REPORTING
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